FDA Product Code QEY: Mechanical Thrombolysis Catheter

Mechanical thrombolysis augments aspiration with active clot disruption. FDA product code QEY covers mechanical thrombolysis catheters used in peripheral and coronary vessels.

These devices use high-velocity fluid jets, rotating elements, or acoustic energy to mechanically fragment thrombus while simultaneously aspirating the debris, enabling more complete clot removal than aspiration alone in acute arterial and venous occlusions.

QEY devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Ekos Corp., Thrombolex, Inc. and AngioDynamics, Inc..